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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Mallinckrodt
Fish and Richardson
Citi
Daiichi Sankyo
Queensland Health
McKesson
US Department of Justice
Accenture

Generated: August 19, 2018

DrugPatentWatch Database Preview

Lenalidomide - Generic Drug Details

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What are the generic sources for lenalidomide and what is the scope of lenalidomide patent protection?

Lenalidomide is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are twenty-three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Lenalidomide has four hundred and eighty-nine patent family members in forty-six countries.

There are fourteen drug master file entries for lenalidomide. One supplier is listed for this compound.

Pharmacology for lenalidomide
Synonyms for lenalidomide
(3S)-3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)piperidine-2,6-dione
1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline
191732-72-6
2, 3-(4-amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-
2,6-Piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-
2,6-piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2H-isoindol-2-yl)-, (3S)-
3-?(4-?AMINO-?1,?3-?DIHYDRO-?1-?OXO-?2H-?ISOINDOL-?2-?YL)-?2,?6-?PIPERIDINEDIONE
3-(4-amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)-2,6-dioxopiperidine
3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)-2,6-piperidinedione
3-(4-Amino-1-oxo-1,3-dihydro-2H-isoindol-2-yl)piperidine-2,6-dione
3-(4-Amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione
3-(4-amino-1-oxo-2,3-dihydro-1H-isoindol-2-yl)piperidine-2,6-dione
3-(4-amino-1-oxo-isoindolin-2-yl)piperidine-2,6-dione
3-(4-Amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione
3-(4-amino-1,3-dihydro-1-oxo-2h-isoindol-2-yl)-2,6-piperidinedione
3-(7-Amino-3-oxo-1H-isoindol-2-yl)-piperidine-2,6-dione
3-(7-amino-3-oxo-1H-isoindol-2-yl)piperidine-2,6-dione
346670-73-3
4-amino-2-(6-hydroxy-2-oxo-2,3,4,5-tetrahydropyridin-3-yl)-2,3-dihydro-1H-isoindol-1-one
443912-14-9
732L726
879126-98-4
AB0017965
AB01273975_03
AB01273975-01
AB01273975-02
ABP001089
AC-914
AC1L50II
AK-47482
AKOS005146276
AKOS005174869
ALBB-015321
AM20050439
AN-1103
API0003142
AX8136128
BC220870
BCP9000847
BCPP000186
BDBM65454
Bio-0168
BR-47482
CAS-191732-72-6
CC 5013
CC-5013
CC-5013, Revlimid, Lenalidomide
CC5013
CDC 501
CDC-501
CDC-5013
Celgene brand of lenalidomide
CHEBI:63791
CHEMBL848
CS-0125
CTK8E1915
D04687
D0Q5NX
DB00480
DSSTox_CID_26664
DSSTox_GSID_46664
DSSTox_RID_81806
DTXSID8046664
ENMD 0997
ENMD-0997
FT-0659651
FT-0670758
GOTYRUGSSMKFNF-UHFFFAOYSA-N
GTPL7331
HE054620
HE247796
HE302018
HE337084
HE343617
HMS3654G07
HY-A0003
I06-0831
IMid-1
IMID-5013
IMiD3
IMiD3cpd
KB-53181
KS-00000GHH
KS-1207
Lenalidomide (CC-5013)
Lenalidomide (Immunomodulator)
Lenalidomide (USAN/INN)
Lenalidomide [USAN:INN:BAN]
Lenalidomide [USAN]
Lenalidomide hydrate
LS-184040
MCULE-9771679074
MFCD07772307
MLS003899194
MolPort-003-848-370
NCGC00167491-01
NCGC00167491-02
NCGC00167491-03
NCGC00167491-04
NSC-747972
NSC747972
PubChem19113
Q-101410
Revamid
Revimid
Revlimid
Revlimid (Celgene)
Revlimid (lenalidomide)
Revlimid (TN)
Revlimid (TN) (Celgene)
Revlimid, Lenalidomide, CC-5013
RTR-008901
S-4172
s1029
SCHEMBL1980410
SCHEMBL32978
SMR002529986
SR-01000883999
SR-01000883999-1
STK639603
Thalidomide analog CC-5013
Tox21_112492
Tox21_112492_1
TR-008901
Z1741976709
ZX-AN014029

US Patents and Regulatory Information for lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-004 Jun 29, 2006 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-006 Jun 5, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for lenalidomide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-001 Dec 27, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-003 Jun 29, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Celgene REVLIMID lenalidomide CAPSULE;ORAL 021880-005 Dec 21, 2011 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for lenalidomide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,767,326 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug ➤ Try a Free Trial
7,874,984 Methods for delivering a drug to a patient while preventing the exposure of a foetus or other contraindicated individual to the drug ➤ Try a Free Trial
6,869,399 Methods for delivering a drug to a patient while restricting access to the drug by patients for whom the drug may be contraindicated ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for lenalidomide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
642 Luxembourg ➤ Try a Free Trial PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805
2 50002-2015 Slovakia ➤ Try a Free Trial PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
90004-6 Sweden ➤ Try a Free Trial PRODUCT NAME: POMALIDOMIDE AND PHARMACEUTICALLY ACCEPTABLE SALTS, SOLVATES, HYDRATES OR STEREOISOMERS THEREOF; REG. NO/DATE: EU/1/13/850 20130808
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Colorcon
US Army
Johnson and Johnson
Harvard Business School
QuintilesIMS
Merck
Chinese Patent Office
Cerilliant

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